Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337

Hyperlipidemias Clinical Trial

Official title:

Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337 in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793985
• Other study ID #: 152BE17006
• Status: Completed
• Phase: Phase 1
• Start date: September 5, 2018
• Est. completion date: November 13, 2018

Study information

• Verified date: January 2019
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337 combination

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 13, 2018
• Est. primary completion date: October 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Between 19 aged and 45 aged in healthy male adult

2. Over 50 kg, BMI between 18.0-29.0 kg/m2

3. Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.

4. Not abnormal or not clinically significant lab values.

5. Subjects who signed informed consent form with good understandings after explanations by investigators.

Exclusion Criteria:

1. No history or presence of clinically significant diseases.

2. Subjects showing adverse reaction to investigational product

3. Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.

4. History of myopathy

5. Subjects with abnormal lab values at least one below 1) AST or ALT>2 fold of upper normal limit 2) Total bilirubin>2 fold of upper normal limit 3) CK>2 fold of upper normal limit 4) Estimated Glomerular filtration rate<60mL/min/1.73m2

6. Drink over 21 units/week (1 unit= 10g=12.5mL of pure alcohol) or unable to stop drinking during clinical trials

7. Smoke over 10 cigarettes per day or unable to stop smoking

8. Subjects who previously participated in other clinical trials within 90 days

9. Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days

10. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 10 days.

11. Taking medications which induce or block medication metabolism

12. History of drug abuse

13. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.

14. Disagree to contraception

15. Subjects who are in any conditions impossible participating in the clinical trials

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• T
CKD-391 40/10mg
• R
D086 and D337 co-administration

Locations

Country	Name	City	State
Korea, Republic of	INHA University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax	0~72hours
Primary	AUCt	To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt	0~72hours